Knee OsteoarthritisNCT05693493
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
A study testing Proprioceptive knee brace in people with Knee Osteoarthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Osteoarthritis is among the most prevalent form of degenerative joint disease in arthritis. The World Health Organisation identified osteoarthritis as one of the top ten most disabling cause of disease in developed countries, and the single most common cause of disability for elderly persons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Proprioceptive knee brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Sep 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age over 18 years old) underwent Total Knee Arthroplasty within 2 to 4 weeks;
- Adult who is able to provide written consent and compliance with treatment and assessment regime
Who cannot join
- Patients with disabilities, wheelchair dependence for mobility;
- Underwent revision Total Knee Arthroplasty;
- Found with complication wounds following surgery;
- Diagnosed with comorbidities e.g. inflammatory arthritis, obesity, dermatological disorders that might affect their compliance to treatment;
- Do not fit to the sizes of knee braces;
- Not to given written consent and be non-compliance with the treatment and assessment regime
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Michael Tim-Yun Ong, 26364171, michael.ong@cuhk.edu.hk
About this study
Official title: Can Proprioceptive Knee Brace Improve Functional Outcome Following Total Knee Arthroplasty?
Osteoarthritis is among the most prevalent form of degenerative joint disease in arthritis. The World Health Organisation identified osteoarthritis as one of the top ten most disabling cause of disease in developed countries, and the single most common cause of disability for elderly persons. In fact, worldwide statistics for men and women over 60 years of age with signs of symptomatic osteoarthritis are estimated to be at 9.6% and 18.0% respectively. In Hong Kong, the latest census revealed that 514,000 people suffer from degenerative arthritis, representing 0.7% of the population. Although these values are much lower than the international figures reported by the WHO, it is inevitable that the prevalence of osteoarthritis will continue to rise with an increasing trend of obesity and an aging population in Hong Kong. Similar to any other chronic disease with wide prevalence, the impact of osteoarthritis translates to a substantial socioeconomic burden on a societal level.
Total knee arthroplasty has become the gold standard to manage the pain and disability associated with end-stage arthritis who have exhausted all conservative measures. Although contemporary advances in prosthesis design, surgical techniques, postoperative rehabilitation regimes have hasten patient's recovery, the restoration of proprioception and neuromuscular control is often prolonged despite solid rehabilitation regimes.
Knee bracing is one of the non-pharmacological modalities designed to evenly distribute load and provide proprioceptive feedbacks for those with knee injuries or knee pain. There are four categories of knee braces for the purpose of prophylactic, functional, rehabilitative and unloader/off-load. This study will mainly be focusing on the effects of the unloader/off-loader brace. Previous studies have demonstrated the effects on alteration of kinematic variables, including range of movement (p=0.002), speed of walking (p<0.001) and knee adduction moment (p=0.001) for knee injuries and osteoarthritis as a part of the conservative management protocol. However, there have few studies that investigated whether proprioceptive knee bracing has any role in functional recovery post total knee arthroplasty.
- Conditions
- Knee Osteoarthritis
- Being tested
- Proprioceptive knee brace
- Keywords
- Knee brace, Knee OA, Proprioceptive knee brace, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive knee braceDevice
For the intervention group that randomly consisted of 15 subjects will be using a design of knee brace (Reaction Web®; DonJoy, Vista, CA). The elastomeric web design helps to reduce pain by dispersing load across the knee. The web acts like a spring to absorb shock and shifts the peak loads away from the painful area of the knee. Elastomeric web acts to dynamically stabilise the patella on all sides, bringing the patella into proper tracking position to reduce pain for patients with general patellofemoral instabilities. Reaction Web® has dual-axis hinges that are flexible, creating synergy with the elastomeric web for optimal fit and support, and providing energy dispersion to the knee.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Device: Proprioceptive knee brace Subjects will use proprioceptive knee brace for 6 weeks post-op, in addition to basic management such as physiotherapy. Receives: Device: Proprioceptive knee brace |
| Control group | No intervention | No device. Subjects will receive basic management such as physiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the time of 6-meter test
The 6-meter test timed walking gait test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Changes of the time of Time up and go test (TUG)
The Time up and go test (TUG) is to determine fall risk and measure the progress of balance, sit to stand and walking. Patients will be asked to stand up from a chair, walk as quickly as possible in their a safe and most comfortable gait until they pass to 3 meters (10 feet) end of marked course with both feet. Turn around and walk back to the chair, time will be counted to the moment until the back of patients touches the back of the chair.
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Change in the range of motion
The active range of motion test predicts the mobility of the joint by measuring the amount of active knee extension and flexion. Knee extension: The patient is supine. The heel of the limb of interest is propped on a bolster, assuring the back of the knee and calf are not touching the support surface. The patient is asked to actively contract the quadriceps. The amount of knee extension is recorded with the goniometer. Knee flexion: The patient is prone. The patient flexes the knee as far as possible. The amount of knee flexion is recorded with the goniometer."
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Secondary outcomes (10)
Knee extensor/flexor strength
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee extension/flexion movement is measured by the dynamometer attached at the malleoli level with a strap.
The measurements will be taken at maximum force for three times.
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Short-form 12
The SF-12 health survey uses 12 questions to measure patient's functional health and well-being from a patient's point of view. It is reliable and validated measure that summaries the patients' physical and mental health. The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations).
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC questionnaire is a questionnaire that measures patient's pain, stiffness and physical function and can be summed up into a score out of 96. A high score indicates a more disabled participant.
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
The Forgotten Joint Score-12
The FJS-12 comprise measures for the assessment of joint-specific patient-reported outcome in their ability to forget about a joint as a result of successful treatment. Join awareness can be simply defined as any unintended perception of a joint.
It is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Knee stability test
KT-1000 will be used at the assessing of knee laxity as it provides an objective evaluation of knee stability resulting from the automated anterior drawer test it performs.
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Knee Society Score (KSS)
The KSS is an instrument assessing patient's pain and functionality based on a series of questions interviewed by a clinician. The validated questionnaire combines the objective physician derived component with a subjective patient derived component which evaluates pain, functionality, satisfaction and fulfillment of expectations. The results will be calculating the total score with 100 being the highest and 0 the lowest.
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Knee Society Function Score (KFS)
The validated questionnaire combines the objective physician derived component with a subjective patient derived component which evaluates pain, functionality, satisfaction and fulfillment of expectations. The results will be calculating the total score with 100 being the highest and 0 the lowest.
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Clinical Research Compliance assessment: compliance to intervention
Clinical Research Compliance assessment will be conducted to measures the period and amount of time designated knee brace has been put on as interventional means.
Measured: 6-weeks, 6-months and 12-months post-op
Clinical Research Compliance assessment: compliance to routine physiotherapy
It recorded the attendance of routine post-operative procedures of physiotherapy training one might receive.
Measured: 6-weeks, 6-months and 12-months post-op
Patients satisfaction Survey
Patients satisfaction Survey is to be recorded in terms not only how well to the quality of care patient was being treated, but to also the content a patient is with the care they received.
Measured: pre-op, 6-weeks, 6-months and 12-months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start26 Sep 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
- Investigators
- Michael Tim-Yun Ong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693493
- Sponsor's protocol ID
- 2022.223-T
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Proprioceptive Knee Brace Improve Functional Outcome Following Total Knee Arthroplasty?
- ClinicalTrials.gov ID
- NCT05693493
- Acronym / sponsor ID
- 2022.223-T
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee brace, Knee OA, Proprioceptive knee brace, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis is among the most prevalent form of degenerative joint disease in arthritis. The World Health Organisation identified osteoarthritis as one of the top ten most disabling cause of disease in developed countries, and the single most common cause of disability for elderly persons. In fact, worldwide statistics for men and women over 60 years of age with signs of symptomatic osteoarthritis are estimated to be at 9.6% and 18.0% respectively. In Hong Kong, the latest census revealed that 514,000 people suffer from degenerative arthritis, representing 0.7% of the population. Although these values are much lower than the international figures reported by the WHO, it is inevitable that the prevalence of osteoarthritis will continue to rise with an increasing trend of obesity and an aging population in Hong Kong. Similar to any other chronic disease with wide prevalence, the impact of osteoarthritis translates to a substantial socioeconomic burden on a societal level.
Total knee arthroplasty has become the gold standard to manage the pain and disability associated with end-stage arthritis who have exhausted all conservative measures. Although contemporary advances in prosthesis design, surgical techniques, postoperative rehabilitation regimes have hasten patient's recovery, the restoration of proprioception and neuromuscular control is often prolonged despite solid rehabilitation regimes.
Knee bracing is one of the non-pharmacological modalities designed to evenly distribute load and provide proprioceptive feedbacks for those with knee injuries or knee pain. There are four categories of knee braces for the purpose of prophylactic, functional, rehabilitative and unloader/off-load. This study will mainly be focusing on the effects of the unloader/off-loader brace. Previous studies have demonstrated the effects on alteration of kinematic variables, including range of movement (p=0.002), speed of walking (p<0.001) and knee adduction moment (p=0.001) for knee injuries and osteoarthritis as a part of the conservative management protocol. However, there have few studies that investigated whether proprioceptive knee bracing has any role in functional recovery post total knee arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Proprioceptive knee braceDevice: Proprioceptive knee brace Subjects will use proprioceptive knee brace for 6 weeks post-op, in addition to basic management such as physiotherapy. |
| Control group | No intervention | –No device. Subjects will receive basic management such as physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (age over 18 years old) underwent Total Knee Arthroplasty within 2 to 4 weeks;
- Adult who is able to provide written consent and compliance with treatment and assessment regime
Key exclusion criteria (6 listed)
- Patients with disabilities, wheelchair dependence for mobility;
- Underwent revision Total Knee Arthroplasty;
- Found with complication wounds following surgery;
- Diagnosed with comorbidities e.g. inflammatory arthritis, obesity, dermatological disorders that might affect their compliance to treatment;
- Do not fit to the sizes of knee braces;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive knee braceFor the intervention group that randomly consisted of 15 subjects will be using a design of knee brace (Reaction Web®; DonJoy, Vista, CA). The elastomeric web design helps to reduce pain by dispersing load across the knee. The web acts like a spring to absorb shock and shifts the peak loads away from the painful area of the knee. Elastomeric web acts to dynamically stabilise the patella on all sides, bringing the patella into proper tracking position to reduce pain for patients with general patellofemoral instabilities. Reaction Web® has dual-axis hinges that are flexible, creating synergy with the elastomeric web for optimal fit and support, and providing energy dispersion to the knee. | Device | Intervention group |
Primary outcome
Changes of the time of 6-meter test
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
The 6-meter test timed walking gait test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).
Changes of the time of Time up and go test (TUG)
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
The Time up and go test (TUG) is to determine fall risk and measure the progress of balance, sit to stand and walking. Patients will be asked to stand up from a chair, walk as quickly as possible in their a safe and most comfortable gait until they pass to 3 meters (10 feet) end of marked course with both feet. Turn around and walk back to the chair, time will be counted to the moment until the back of patients touches the back of the chair.
Change in the range of motion
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
The active range of motion test predicts the mobility of the joint by measuring the amount of active knee extension and flexion. Knee extension: The patient is supine. The heel of the limb of interest is propped on a bolster, assuring the back of the knee and calf are not touching the support surface. The patient is asked to actively contract the quadriceps. The amount of knee extension is recorded with the goniometer. Knee flexion: The patient is prone. The patient flexes the knee as far as possible. The amount of knee flexion is recorded with the goniometer."
10 secondary outcomes
Knee extensor/flexor strength
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
Short-form 12
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
The Forgotten Joint Score-12
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
Knee stability test
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
Knee Society Score (KSS)
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
Knee Society Function Score (KFS)
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
Clinical Research Compliance assessment: compliance to intervention
Time frame: 6-weeks, 6-months and 12-months post-op
Clinical Research Compliance assessment: compliance to routine physiotherapy
Time frame: 6-weeks, 6-months and 12-months post-op
Patients satisfaction Survey
Time frame: pre-op, 6-weeks, 6-months and 12-months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Tim-Yun Ong principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive knee brace in people with Knee Osteoarthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Tim-Yun Ong (26364171, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the time of 6-meter test (time frame: pre-op, 6-weeks, 6-months and 12-months post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.